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Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

Primary Purpose

Arthritis, Arthroscopic Hip Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria: primary THA (cemented or cementless) preoperative diagnosis of osteoarthritis (primary or secondary) meets objective discharge-to-home test following hip replacement ability to speak English and reply to questionnaires written in English ability to provide informed consent may include patients presenting for their second primary hip arthroplasty Discharge to Home Criteria independent supine-to-sit transfer independent sit-to-stand transfer walk with walking aid 30 meters ascend and descend 3 stairs deemed medically fit and safe for home environment by surgeon/nursing/PT Exclusion Criteria: surgery as part of a workers' compensation claim arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy intra-operative complication of fracture or sciatic nerve injury procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach) indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).

    Secondary Outcome Measures

    Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?
    Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
    generic health-related QOL (SF-36) and (HUI3)
    pain and stiffness (WOMAC pain and stiffness)
    activities of daily living (FSI)
    patient satisfaction (Brigham and Women's patient satisfaction)
    objective physical function (TUG, Harris Hip, Gait Lab)
    What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
    How does the recovery over time compare between programs (trajectory of recovery) ?
    What is the difference in musculoskeletal adverse event rate (ie dislocation)?

    Full Information

    First Posted
    September 11, 2005
    Last Updated
    September 24, 2008
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00175448
    Brief Title
    Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery
    Official Title
    A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of British Columbia

    4. Oversight

    5. Study Description

    Brief Summary
    A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis, Arthroscopic Hip Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    144 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    physiotherapy
    Intervention Description
    See Detailed Description.
    Primary Outcome Measure Information:
    Title
    Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?
    Time Frame
    2 years
    Title
    Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
    Title
    generic health-related QOL (SF-36) and (HUI3)
    Title
    pain and stiffness (WOMAC pain and stiffness)
    Title
    activities of daily living (FSI)
    Title
    patient satisfaction (Brigham and Women's patient satisfaction)
    Title
    objective physical function (TUG, Harris Hip, Gait Lab)
    Title
    What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
    Title
    How does the recovery over time compare between programs (trajectory of recovery) ?
    Title
    What is the difference in musculoskeletal adverse event rate (ie dislocation)?

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary THA (cemented or cementless) preoperative diagnosis of osteoarthritis (primary or secondary) meets objective discharge-to-home test following hip replacement ability to speak English and reply to questionnaires written in English ability to provide informed consent may include patients presenting for their second primary hip arthroplasty Discharge to Home Criteria independent supine-to-sit transfer independent sit-to-stand transfer walk with walking aid 30 meters ascend and descend 3 stairs deemed medically fit and safe for home environment by surgeon/nursing/PT Exclusion Criteria: surgery as part of a workers' compensation claim arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy intra-operative complication of fracture or sciatic nerve injury procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach) indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nelson Greidanus, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery

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